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21 U.S.C. § 384e — Recognition of foreign government inspections

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 384e — Recognition of foreign government inspections

**(a) Inspection** The Secretary— (1) may enter into arrangements and agreements with a foreign government or an agency of a foreign government to recognize the inspection of foreign establishments registered under [section 360(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/i&num=0&edition=prelim) in order to facilitate preapproval or risk-based inspections in accordance with the schedule established in paragraph (2) or (3) of [section 360(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/h&num=0&edition=prelim); (2) may enter into arrangements and agreements with a foreign government or an agency of a foreign government under this section only with a foreign government or an agency of a foreign government that the Secretary has determined as having the capability of conducting inspections that meet the applicable requirements of this chapter; and (3) shall perform such reviews and audits of drug safety programs, systems, and standards of a foreign government or agency for the foreign government as the Secretary deems necessary to determine that the foreign government or agency of the foreign government is capable of conducting inspections that meet the applicable requirements of this chapter. **(b) Results of inspection** The results of inspections performed by a foreign government or an agency of a foreign government under this section may be used as— (1) evidence of compliance with [section 351(a)(2)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351/a/2/B&num=0&edition=prelim) or [section 381(r) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/r&num=0&edition=prelim); and

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Source file: Laws/federal/codes/united-states-code/title-21/section-384e-recognition-of-foreign-government-inspections--4d4f150402.md
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Source location: Title 21, Chapter 9, § 384e; chapter-009-federal-food-drug-and-cosmetic-act.md

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360 — Registration of producers of drugs or devices

**(a) Definitions** As used in this section— (1) the term “manufacture, preparation, propagation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user; and (2) the term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. **(b) Annual registration** (1) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address. (2) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments. (3) The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the pr

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 381 — Imports and exports

**(a) Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission** The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or [section 387e(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/h&num=0&edition=prelim) and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of [section 360j(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 384e — Recognition of foreign government in-

Page 662 TITLE 21—FOOD AND DRUGS § 384e (h) Limitations (1) No effect on section 374 inspections The audits performed under this section shall not be considered inspections under sec- tion 374 of this title. (2) No effect on inspection authority Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this chapter. (June 25, 1938, ch. 675, § 808, as added Pub. L. 111–353, title III, § 307, Jan. 4, 2011, 124 Stat. 3959.) Editorial Notes REFERENCES IN TEXT Section 381(q) of this title, referred to in subsec. (c)(2)(C)(ii), was in the original ‘‘301(g)’’, and was trans- lated as reading ‘‘801(q)’’, meaning section 801(q) of act June 25, 1938, ch. 675, which is classified to section 381(q) of this title, to reflect the probable intent of Con- gress, because section 381(q) of this title relates to food certification, whereas section 301(g) of act June 25, 1938, ch. 675, which is classified to section 331(g) of this title, does not relate to food certification. Section 1622(h) of title 7, referred to in subsec. (c)(8), was in the original ‘‘section 203(h) of the Agriculture Marketing Act of 1946’’, and was translated as reading ‘‘section 203(h) of the Agricultural Marketing Act of 1946’’, meaning section 203(h) of act Aug. 14, 1946, ch. 966, which is classified to section 1622(h) of Title 7, Ag- riculture, to reflect the probable intent of Congress. Statutory Notes and Related Subsidiaries CONSTRUCTION Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agree- ments to which the United States is a party, see sec- tions 2206, 2251, and 2252 of

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